Canon TX-F User manual

Before using the instrument, be sure to read this manual thoroughly.
Keep the manual where it is easily accessible.
Operation Manual

PLEASE NOTE
1. The user is responsible for the use and maintenance of the product. We suggest that a
member of the user’s staff be designated as being in charge of maintenance so as to
ensure that the product is kept in a safe and good condition.
Also, medical products must be used only by a qualified person.
2. In no event will Canon be liable for direct or indirect consequential damage arising out of
the use of this product.
3. This product may malfunction due to electromagnetic waves caused by portable personal
telephones, transceivers, radio-controlled toys, etc. Be sure to avoid having objects such
as these, which affect this product, brought near the product.
4. Canon reserves the right to change the specifications, configuration and appearance of
the product without prior notice.
© CANON INC. 2004
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the written
consent of Canon.

(1)
Safety Information
Regulations
For U.S.A.
Federal law restricts this device to sale by or on the order of an ophthalmologist or optometrist.
This instrument is a CLASS I EQUIPMENT and TYPE B APPLIED PARTS according to
UL2601-1.
Do not make any changes or modifications to the equipment unless otherwise specified in the
manual.
If such changes or modifications should be made, you could be required to stop operation of
the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class A dig-
ital device, pursuant to Part 15 of the FCC rules.
These limits are designed to provide reasonable protection against harmful interfer-
ence when the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interfer-
ence in with case the user will be required to correct the interference at his own
expense.
Use of shielded cable is required to comply with class A limits in Subpart B of part 15 of FCC
rules. The following mark shows compliance of the instrument with Directive 93/42/EEC.
For Canada
This equipment complies with the Canadian ICES-003 class A specifications.

(2)
Safety Information
General Safety Information
Follow the safety instructions in this manual and all warnings and cautions printed on the warning
labels. Ignoring such cautions or warnings while handling the product may result in injury or accident.
Be sure to read and fully understand the manual before this product.
Keep this manual for future reference.
Meaning of Caution Signs
WARNING This indicates a potentially hazardous situation which, if not heeded, could
result in death or serious injury to you or others.
CAUTION This indicates hazardous situation which, if not heeded, may result in minor or
moderate injury to you or others, or may result in machine damage.
NOTE This is used to emphasize essential information.
Be sure to read this information to avoid incorrect operation.
Environment of Use and Storage
WARNING
Do not use or store the instrument near any flammable chemicals such as
alcohol, thinner, benzine, etc. If chemicals are spilled or evaporate, it may
result in fire or electric shock through contact with electric parts inside the
instruments. Also, some disinfectants are flammable.
Be sure to take care when using them.
WARNING
Do not use or store the instrument in a location with the conditions listed
below. Otherwise, it may result in failure or malfunction, fall or cause fire or
injury.
- Close to facilities where water is used.
- Where it will be exposed to direct sunlight.
- Close to air- conditioner or ventilation equipment.
- Close to heat source such as a heater.
- Prone to vibration.
- Insecure place.
- Dusty environment.
- Saline or sulfurous environment.
- High temperature or humidity.
- Freezing or condensation.
CAUTION Place the instrument on a firm table
Do not place it extremely near the edge of the table in order to avoid damage
or injury due to falling.
CAUTION Do not cover the vent holes on the cover.
Otherwise, the temperature in the instrument may rise and cause fire.
!
!
!
!
!
!

Safety Information
(3)
Installation Operation
WARNING
Do not connect the instrument with anything other than specified.
Otherwise, it may result in fire or electric shock.
Also, when other equipment is going to be connected to the instrument using
the connector for interface, be sure to check after connection that leakage cur-
rent is within the tolerable value.
For details, please contact Canon representative or distributor.
Power Supply
WARNING Only operate the instrument with the type of power supply indicated on the rat-
ing label. Otherwise, it may result in fire or electric shock.
WARNING
Be sure to disconnect/connect the cables as indicated in this manual.
The unit weighs 21 kg, so bear in mind that it may tip over if proper care is not
taken.
Also, do not handle them with wet hands. Otherwise, you may get an electric
shock that may result in death or serious injury.
WARNING Securely plug in the power cable into the AC outlet.
If contact failure occurs, or if dust or metal object comes in contact with the
exposed metal prong of the plug, fire or electric shock may result.
WARNING Be sure to hold the plug or connector to disconnect the cable.
If you pull the cable, the core wire may be damaged, resulting in fire or electric
shock.
WARNING
Do not cut or process the cables. Also, do not place anything heavy, including
the instrument on it, step on it, pull it, bend it, or bundle it.
Otherwise, the cable may be damaged, which may result in fire or electric
shock.
WARNING Do not get the power for more than one instrument from the same AC outlet.
Otherwise, if may result in fire or electric shock.
CAUTION The instrument is shipped with a grounding type (three-core) power cable.
To reduce the risk of electric shock, always plug the cable into a grounded
power outlet.
CAUTION To make it easy to disconnect the plug at any time, avoid putting any obstacles
near the outlet.
!
!
!
!
!
!
!
!
!

(4)
Safety Information
Handling
WARNING Do not measure an eye of which cornea is frail due to corneal disease or due
to it having undergone an operation. Otherwise, complications may occur.
WARNING
Never disassemble or modify the product as it may result in fire or electric
shock. Also, since the instrument incorporates high-voltage parts that may
cause electric shocks and other hazardous parts, touching them may cause
death or serious injury.
WARNING
Do not place anything on top of the instrument.
Otherwise, the object may fall and cause injury.
Also, if metal objects such as needle or clip falls into the instrument, or if liquid
is spilled, it may result in fire or electric shock.
WARNING
When the instrument is going to be moved, be sure to turn OFF the power
switch, unplug the power cable from the AC outlet, and disconnect other
cables. Otherwise, cable may be damaged, which may result in fire or electric
shock.
Also, when the instrument is going to be carried, be sure to support the bot-
tom of the instrument an hold it horizontally.
Do not hold it by the face rest poles or other parts, as they may come off and
result in injury.
WARNING Do not hit or drop the instrument. The instrument may be damaged if it
receives a strong jolt, which may result in fire or electric shock if the instru-
ment is used without it being repaired.
CAUTION Wipe the forehead rest with ethanol or glutaraldehyde solution to disinfect it
each time a different patient uses the instrument, in order to prevent infection.
Please consult a specialist for the procedure for disinfection.
CAUTION Change the chin rest paper each time the examinee changes in order to keep
the chin rest clean.
CAUTION Measurement head moves when the instrument is initializing or after printing
the result. Do no have the examinee place his/her face on the chin rest until
movement is completed. Otherwise, the examinee may be hurt.
CAUTION
Set the position where to stop the measurement head with the LIMITER
switch each time the examinee changes in order to prevent accidental contact
of nozzle with examinee. Be sure to look from side of the examinee when
deciding the stop position. If the stop position is not set correclty, the exam-
inee may be injured. Also, if the message “LIMITER OFF” does not disappear
even after LIMITER switch pressed several times, stop the measurement and
contact Canon representative or distributor.
CAUTION Do not have the examinee place his/her hand or fingers under the chin rest or
near the measurement head. Otherwise, injury may result.
CAUTION Do not touch the cutter of the printer. Otherwise, fingers may be cut.
CAUTION When the instrument is not going to be used, turn OFF the power switch.
Also, unplug the power cable from the AC outlet when it is not going to be
used for a long time.
!
!
!
!
!
!
!
!
!
!
!
!

Safety Information
(5)
CAUTION
This instrument uses a lithium battery, which may pollute the environment if
the instrument is abandoned.
Please contact Canon representative or distributor before disposing of the
instrument.
When Problem Occurs
WARNING
Should any of the following occur, immediately turn OFF the power of each
instrument, unplug the power cable from the AC outlet, and contact Canon
representative or distributor.
- When there is smoke, odd smell or abnormal sound.
- When liquid has been spilled into the instrument or a metal object has
entered through an opening.
- When the instrument has been dropped and it is damaged.
Maintenance and Inspection
WARNING For safety reasons, be sure to turn OFF the power of each instrument when
the inspections indicated in this manual are going to be performed.
Otherwise, it may result in electric shock.
WARNING
When the instrument is going to be cleaned, be sure to turn OFF the power of
each instrument, and unplug the power cable from the AC outlet.
Never use benzine, thinner or any other flammable cleaning agents.
Otherwise, fire or electric shock may result.
WARNING
Clean the plug of the power cable periodically by unplugging it from the AC
outlet and removing dust or dirt from the plug, its periphery and AC outlet with
a dry cloth. If the cable is kept plugged in for a long time in a dusty, humid or
sooty place, dust around the plug will attract moisture, and this could cause
insulation failure which could result in a fire.
WARNING The instrument must be repaired by a qualified engineer only.
If it is not repaired properly, it may cause fire, electric shock, or accident.
CAUTION For safety reasons, be sure to inspect the instrument before using it.
Handling
!
!
!
!
!
!
!

(6)
Safety Information
Rating Label and Warning Label
The TX-F has a rating label and a warning label on it.
Contents of those and positions where they are attached are indicated below.
See manual
Mirar el manual
Warning Label
This unit weighs 21 kg –
it may tip over if proper care is
not taken.
Rating Label
This mark indicates that this
is a Type B Applied Part
according to UL2601-1/
EN60601-1.
This unit can be installed in
the patient environment.

Contents
Safety Information ................................................................................................ (1)
1. Overview ........................................................................................................ 1
2. Notes for Using the Instrument ...................................................................... 2
3. Description ..................................................................................................... 3
3.1 Main Unit ......................................................................................................................3
3.2 Connectors under the Main Unit ..................................................................................5
3.3 Operation Panel ...........................................................................................................6
3.4 Display on Measurement Screen .................................................................................8
3.5 Display on DISPLAY and SET Modes Screens ...........................................................11
4. Measurement Modes ..................................................................................... 12
4.1 Measurement Modes ...................................................................................................12
4.2 Relation between Settings and Measurement Operation ............................................13
5. Measurement ................................................................................................. 15
5.1 Preparation ..................................................................................................................15
5.2 FULL AUTO/AUTO Measurement ...............................................................................20
5.3 MANUAL Measurement ...............................................................................................27
6. Measurements Stored in Memory [DISPLAY Mode] ...................................... 31

7. Various Settings [SET Mode] ......................................................................... 32
7.1 Settings for Measurement (Page: 1/3) .........................................................................33
7.2 Settings for Printing and Transfer (Page: 2/3) .............................................................36
7.3 Entering Message for Internal Printer (Page: 3/3) .......................................................39
8. Daily Inspection and Maintenance ................................................................. 43
8.1 Inspection ....................................................................................................................43
8.2 Before Calling a Service Person ..................................................................................45
8.3 Cleaning and Disinfection ............................................................................................51
8.4 Replacement ................................................................................................................55
8.5 Expendable Parts List ..................................................................................................59
9. Installation ...................................................................................................... 60
9.1 Installation ....................................................................................................................60
9.2 Precautions when Moving the Instrument ....................................................................62
10. Service Information ...................................................................................... 63
11. Specifications ............................................................................................... 64
12. Components ................................................................................................. 66

– 1 –
1. Overview
The Canon Full Auto Tonometer TX-F is an instrument for measuring intraocular pressure
without making contact with examinee’s eye.
Just by displaying the examinee’s eye somewhere on the monitor and pressing the START
switch, the TX-F then automatically performs alignment and measurement by a three
dimensional tracking system.
Measurement mode can be selected
The examiner can select a measurement mode from three modes: FULL AUTO, AUTO and
MANUAL.
In FULL AUTO mode, measurement of both eyes will be performed automatically.
Also, the result can be selected to be printed automatically after measuring both eyes.
Thus, full measurement can be done very easily in a short time.
In AUTO mode, alignment and measurement will automatically be performed once each
time the START switch is pressed. Thus, you can perform measurement after checking the
condition of examinee’s eye each time. Also, you can measure the eye as many times as
required.
In MANUAL mode, measurement can be performed manually when examinee’s pupil is
eccentric, or when measurement is apt to result in error.
Observation range of examinee’s eye on the monitor has been
widened and the depth of focus is deep
It is easier to check the position of the eye or whether eyelashes are covering the pupil.
Level meter will be displayed
The TX-F obtains intraocular pressure from the waveform of the signal obtained by detect-
ing light reflected from the cornea when air is blown onto the eye.
However, when the reflected light is obscured by the eyelid or eyelashes, the waveform of
the signal becomes low, reducing the reliability of the measurement value.
The level of the waveform can be displayed in four steps as a mark (“level meter”) on the
measurement mode screen, display mode screen and the printout by the setting in SET
mode. Thus, the level meter can be used to check the reliability of the measured values.
When error has occurred, image will be displayed immediately
on the monitor
This makes it easier to determine the cause of the measurement error.
Also, the eyelid warning line on the warning image will enable you to see if the eyelid or
eyelashes were too low during measurement. If the eyelid or eyelashes are below the line,
help the examinee open the eye wide by gently holding up the upper eyelid with your fin-
gers.

– 2 –
2. Notes for Using the Instrument
Before Use
(1) Sudden heating of the room in cold ares will cause condensation to form on the pro-
tective glass in the measurement window and on optical parts inside the instrument. In
this case, wait until condensation disappears before performing measurement.
During Measurement
(1) Before measurement, explain about the measurement that is going to be performed to
the examinee so he/she will not be surprised by a sudden air puff. Demonstrate the
intensity of the air puff by having the examinee place a finger in front of the nozzle
and pressing the CLEAR (DEMO) switch for more than 2 seconds.
(2) Measurement head automatically moves after the power is turned ON. Do not prevent
movement of measurement head by holding it or placing something near it.
(3) It is recommended that a hard copy of the printout be made if you wish to store it for a
long time, because printouts on thermal paper are apt to deteriorate.
After Use
(1) Turn OFF the power, put the cap over the nozzle in order to prevent dust from attach-
ing to it, and place the dust cover over the instrument.
During Cleaning and Disinfection
(1) If the surface of the objective lens on the nozzle is wiped when dust or dirt is on it, it
will be scratched. Also, do not wipe the objective lens with ethyl alcohol or with
cleaning paper containing silicone. Otherwise, the surface will be corroded, or will be
stained. See section 8.3.2.
(2) Do not use alcohol, benzine or thinner for cleaning the cover of the instrument. Also,
never wipe the cover with ethanol or glutaraldehyde solution. Otherwise, coating will
be corroded. See section 8.3.4.
Environment of Use
(1) After a long time of use, dust in the air will attach not only on the nozzle, but also on
optical parts inside the instrument, which may cause incorrect measurement, Always
keep the room clean.
During Installation
(1) Handle the instrument carefully, as preadjustment may be altered if the instrument
receives a strong jolt.
(2) Do not install the instrument where it will be exposed to direct sunlight. Otherwise, it
will be hard to see the monitor properly, or you may not be able to obtain a correct
measurement.
(3) Blow off the dust in the connectors of the cables with a blower before connecting
them. Otherwise, connection failure may occur.
(4) Do not lay the instrument on its side when the power is turned ON. Otherwise, the
instrument will malfunction.
(5) When the instrument is going to be transported, it must be protected against vibration
and shocks. Contact Canon representative or distributor for advice on the procedure
for packing it.

– 3 –
3. Description
3.1 Main Unit
3.1.1 Examiner’s Side
Brightness adjuster
Adjusts brightness of monitor.
Contrast adjuster
Adjusts contrast of monitor.
Measurement head
Unit that performs measurement.
Height adjustment mark
Align the height of the
examinee’s eye with this
mark by adjusting the
height of chin rest.
Monitor
Displays the screen for measure-
ments and various settings.
Operation panel
See section 3.3.

3.1 Main Unit
– 4 –
3.1.2 Examinee’s Side
Chin rest
Place the examinee’s chin on
this rest.
Nozzle
Supplies air used for mea-
surement.
Must be always kept clean.
Forehead rest
Place the examinee’s fore-
head against this rest.
Printer
Prints measurements.
Rating label
Name of the product,
rated voltage, serial num-
ber, etc. are indicated on
the label.
Power switch
Switch for turning power
ON and OFF.
External eye fixation lamp
Lamp to be used when the
examinee’s eye cannot be fixed
by the internal eye fixation
lamp.

3.2 Connectors under the Main Unit
– 5 –
3.2 Connectors under the Main Unit
Grounding terminal
Terminal for grounding the instru-
ment.
RS232C Connector
RS232C connector for con-
necting external instrument.
External instrument must be
connected in compliance with
the IEC601-1-1 standard.
Power supply connector
Connector for the power
supply cable.

3.3 Operation Panel
– 6 –
3.3 Operation Panel
R
C
L
DISP./SET FIXATION LIMITER
READY
CLEAR
(DEMO) PUFF
TIMES AUTO/
MANU.
CHIN REST
3/1
IN/EX
A/M
DISP./SET switch
Press this switch in order to enter
DISPLAY mode, where you can see
measurement data stored in memory.
You can enter SET mode, where var-
ious settings can be made, from
DISPLAY mode.
FIXATION switch
Each time the switch is
pressed, the eye fixation
lamp switches between
internal and external.
When the external eye
fixation lamp is ON, the
lamp below the switch
lights.
PRINT switch
Press this switch in
order to print or
transfer the mea-
surement manually.
Trackball
Moves the measurement head up
and down, right and left.
LIMITER switch
Switch for stopping the measurement head
in a certain position in order to prevent the
nozzle accidentally hitting the examinee’s
eye.
START switch
When this switch is pressed in FULL AUTO
or AUTO mode, automatic alignment and
measurement are performed. In MANUAL
mode, only measurement is performed.
R/L switch
Each time the switch is
pressed, the measurement
head moves either to the
right or left eye.

3.3 Operation Panel
– 7 –
R
C
L
DISP./SET FIXATION LIMITER
READY
CLEAR
(DEMO) PUFF
TIMES AUTO/
MANU.
CHIN REST
3/1
IN/EX
A/M
CLEAR (DEMO) switch
This switch has two functions.
If printing is not necessary after the mea-
surement, press this switch for an instant.
Displayed measurement will be deleted,
clearing the display for the next examinee.
Or, if the switch is pressed for more than
two seconds, air will be emitted from the
nozzle for demonstrations of air puff.
PUFF TIMES switch
Each time the switch is
pressed, the number of times
of measurement (1 or 3) in
FULL AUTO mode can be
selected. The number of
times will be displayed
within the brackets next to
“FULL AUTO”.
AUTO/MANU. switch
Press this switch to select measurement mode
(FULL AUTO/AUTO/MANUAL). The selected
mode will be displayed on the upper left side of
the monitor. Lamp above the switch lights when
FULL AUTO or AUTO mode is selected.
CHIN REST switches
Switches for raising/lowering the chin rest.
READY lamp
It is ON when the instrument is ready for
measurement, and blinksduringinitialization
or when power-saving system is operating.
Roller
Moves the measurement head back and
forth.

3.4 Display on Measurement Screen
– 8 –
3.4 Display on Measurement Screen
The screen below is an example when FULL AUTO mode is selected.
3.4.1 Before Measurement
FULLAUTO(3) LIMITER OFF No. 000001
mmHg
STD
[ , , ]
L [ , , ]
30
R
Right or left side eye
The display of the side of the eye
where the measurement head is
positioned will be reversed.
Condition of limiter
When the limiter for preventing the
nozzle from coming into contact
with examinee’s eye is not working,
message “LIMITER OFF” will be dis-
played.
Limiter can be set to ON/OFF with
LIMITER switch. See section 5.1.
Serial number
Serial number is displayed when “COUNT”
on page 1/3 of SET mode is set to “ON”.
The initial value can also be set from the
same page of SET mode.
Measurement mode
Measurement mode (FULL
AUTO, AUTO or MANUAL) is
displayed. Measurement mode can
be selected with AUTO/MANU.
switch.
Number of times of measurement
The number of times of measurement (1 or 3) to be per-
formed in FULL AUTO mode is displayed.
It is not displayed in AUTO and MANUAL mode.
Number of times can be selected by pressing PUFF
TIMES switch.
Order of displaying the result
Order of displaying the result (“ ”
for reliability or “ ” for sequence)
is shown. Order can be selected
from “ORDER” on page 1/3 of SET
mode.
Measurement range
Measurement range (“30” for 0 –
30 mmHg or “60” for 25 – 60
mmHg) is displayed. It can be
selected from “RANGE” on page
1/3 of SET mode.
Unit of intra-ocular pressure
Alignment ring
This is the ring used for
positioning the examinee’s
pupil during manual mea-
surement.

3.4 Display on Measurement Screen
– 9 –
3.4.2 After Measurement
When measurement has been done normally
Level meter
Level meter is a mark that shows the level of the waveform of the signal
obtained by detecting light reflected from the cornea when air is blown onto
the eye.
When reflected light is obscured by the eyelid or eyelashes, the waveform of
the signal becomes low, reducing the reliability of the measurement value.
Therefore, the level meter can be used to check the reliability of the measured
values.
To display the level meter, set “( ) LEVEL” to ON as described on page 2/3
of SETmode.Level meter of the newest measurement will be displayed on the
measurement mode screen. Level meter of all the measured values can be seen
in the display mode screen.
NOTE: Maximum level of the level meter differs for each eye, due to differ-
ences in corneal reflection rates.
FULLAUTO(3) No. 000001
mmHg
STD
[ , , ]
[ , , ]
30
R 17 8 7 7.2
9 9 8 8.9
L
STD value
The value calculated from measurement data (maximum
of 10 data) in memory is displayed. The upper data is the
right side eye’s STD value, and the lower one is the left
side eye’s value.
After the first measurement:
Value to the first decimal place
After the second measurement:
Value with higher reliability
After more than three measurements:
The most appropriate value “standard value” obtained
by reliability and statistically processing the data.
However, measurement with low reliability mark (*)
will not be included in the calculation.
Measurement data
Maximum of three measurements are displayed in the
order set from “ORDER” on page 1/3 of SET mode.
The upper row is the data of the right side eye, and the
lower row is the data of the left side eye.
Maximum of 10 measurements for each eye can be seen in
DISPLAY mode. See chapter 6.
Serial number
Serial number counts up after printing, transferring or
deleting the data, or after function is restored from the
power-saving mode if “COUNT” on page 1/3 of SET mode
is set to “ON”.
Low reliability mark (*)
Mark that appears when the reliability of the measurement
has been determined to be low after multiple measurement
values have been statistically analyzed.
The height of the signal waveform was high.
The height of the signal waveform was low.

3.4 Display on Measurement Screen
– 10 –
When measurement error has occurred
FULLAUTO(3)
No. 000001
mmHg
STD
[ , , ]
L[ , , ]
30
R ERROR
Warning image
Eye front image when measurement error has
occurred will be displayed if “WARNING IMG” is
set to “ON” on page 1/3 of SET mode.
Warning image will not be displayed when error
is caused by blinking or when result is over the
measurement range, etc.
Eyelid warning line
If the eyelid or eyelashes are below the eyelid
warning line on the image, instruct the examinee
to keep the eye open wide, or help them open
their eye wide.
ERROR display
“ERROR” is displayed when measurement
was a failure. Take the required measures
and try again.